CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Tocilizumabdrug
Likely dose
Tocilizumab 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03923738
NCT03923738Phase 1Completed

A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis

Hoffmann-La Roche·interventional·Posted Apr 23, 2019·Updated Dec 22, 2021

In Brief

A Phase 1 clinical trial evaluating Tocilizumab for Giant Cell Arteritis. Completed, enrolled 24 participants across 2 sites.

Detailed Summary

This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 23, 2019
Enrollment StartAug 5, 2019
Primary CompletionNov 12, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.2 years ago

Interventions

Tocilizumabdrug

TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.